Label: CLE CCC NEUTRAL MEDIUM- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 69231-030-01, 69231-030-02
- Packager: KW ABSC, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 18, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Cyclohexasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Iron Oxides (CI 77492), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Iron Oxides (CI 77491), Disteardimonium Hectorite, Iron Oxides (CI 77499), Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Dimethicone, Vegetable Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenyl Trimethicone, Dimethicone Crosspolymer, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Glycerin, Melissa Officinalis Leaf Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Veronica Officinalis Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLE CCC NEUTRAL MEDIUM
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69231-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.1 mg in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.9 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.7888 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMILOXATE (UNII: 376KTP06K8) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) NIACINAMIDE (UNII: 25X51I8RD4) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BEMOTRIZINOL (UNII: PWZ1720CBH) CERESIN (UNII: Q1LS2UJO3A) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) SORBITAN OLIVATE (UNII: MDL271E3GR) POLYESTER-10 (UNII: 212N9O2MMZ) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) CHLORPHENESIN (UNII: I670DAL4SZ) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) CORN OIL (UNII: 8470G57WFM) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BERGAMOT OIL (UNII: 39W1PKE3JI) ORANGE OIL (UNII: AKN3KSD11B) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ADENOSINE (UNII: K72T3FS567) CANANGA OIL (UNII: 8YOY78GNNX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69231-030-02 1 in 1 PACKAGE 10/18/2022 1 NDC:69231-030-01 30 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/18/2022 Labeler - KW ABSC, INC. (079548604) Registrant - KW ABSC, INC. (079548604) Establishment Name Address ID/FEI Business Operations Cit Co., Ltd 690081646 manufacture(69231-030)
